Structural Heart Disease

Structural heart diseases include any issues preventing normal cardiovascular function due to damage or alteration to the anatomical components of the heart. This is caused by aging, advanced atherosclerosis, calcification, tissue degeneration, congenital heart defects and heart failure. The most commonly treated areas are the heart valves, in particular the mitral and aortic valves. These can be replaced through open heart surgery or using cath lab-based transcatheter valves or repairs to eliminate regurgitation due to faulty valve leaflets. This includes transcatheter aortic valve replacement (TAVR). Other common procedures include left atrial appendage (LAA) occlusion and closing congenital holes in the heart, such as PFO and ASD. A growing area includes transcatheter mitral repair or replacement and transcatheter tricuspid valve repair and replacement.

First patient treated with BASILICA before valve-in-valve TAVR in a mechanically-expanded valve
A heart team chose to perform BASILICA before valve-in-valve TAVR in a failed Lotus device to help minimize the risk of complications. These scenarios will likely grow more and more common as patients outlive their TAVR valves.
FDA clears AI-powered software for real-time TAVR guidance
Caranx Medical is focused on using AI, robotics and other advanced technologies to expand patient access to life-saving procedures. This new software, for example, helps guide cardiologists through complex TAVR procedures.
Myval TAVR valve associated with positive durability data after 4 years
Researchers have been spending more and more time evaluating the Myval TAVR valve from Indian medtech company Meril Life Sciences. The balloon-expandable device is available in some parts of the world, but not the United States.
Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation
CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.
New TAVR valve from MiRus linked to positive early outcomes
The Siegel TAVR valve includes no nickel or cobalt. In fact, its frame was built using special alloys specifically developed by MiRus.

LUMA Vision Verafeye Visualization Platform

FDA clears catheter-based 4D visualization platform for complex heart procedures

The new technology from LUMA Vision allows operators to deliver 2D and 4D ultrasound images in real time. The advanced catheter was built with maneuverability and increased visibility in mind.

No longer the ‘forgotten valve’: Tricuspid valve surgery outcomes keep improving

Patient outcomes after tricuspid valve replacement have improved significantly over the years, according to new data published in The Annals of Thoracic Surgery.

Edwards Lifesciences announces key approval for new mitral valve replacement system

The Sapien M3 device was designed to treat symptomatic mitral regurgitation in patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Why surgery, not TAVR, remains the best treatment for some AS patients

TAVR is being used in more patients to treat severe aortic stenosis. However, according to a new commentary piece, SAVR is still the smartest treatment option for certain populations, including younger patients with bicuspid aortic valves.

Raj Makkar, MD, director, interventional cardiology, director, Interventional Cardiology Research Program and professor of medicine, Smidt Heart Institute, Cedars-Sinai Hospital, presented the late-breaking Align-AR clinical trial at ACC 2025 on the first 500 patients treated for aortic regurgitation using the Jena Valve transcatheter aortic valve replacement (TAVR) device.

First 500 patients in Align-AR trial using TAVR for pure aortic regurgitation show strong outcomes

Raj Makkar, MD, Cedars-Sinai, explains the late-breaking data from the Align-AR trial on the first 500 patients treated for aortic regurgitation using the Jena Valve TAVR device.

The Agitation Solutions Orbis Microbubble Generator simplifies and streamlines the process of saline agitation and delivery for cardiac bubble studies using a single use syringe. It is was cleared for use in Canada in 2024.

Right heart cardiac ultrasound contrast agent for shunts enters U.S. trial

Currently there are no FDA cleared echocardiography contrast agents commercially available for use on the right side of the heart to detect shunts, but a new agent that promises to improve workflow and imaging is about to enter a U.S. trial.

Michael Reardon, MD, explained the low-risk Evolut 5-year results of TAVR vs. SAVR at ACC 2025. #ACC #ACC25 #ACC2025

5-year Evolut Low Risk Data: Durable clinical outcomes, outstanding valve performance

Structural Heart Disease

First patient treated with BASILICA before valve-in-valve TAVR in a mechanically-expanded valve

FDA clears AI-powered software for real-time TAVR guidance

Myval TAVR valve associated with positive durability data after 4 years

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

New TAVR valve from MiRus linked to positive early outcomes